EN 1060-3:1997+A2:2009
(Main)Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods.
This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically.
Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995.
This Part of EN 1060 is to be used in conjunction with EN 1060-1.
Nichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische Blutdruckmesssysteme
Dieser Teil der EN 1060 legt Anforderungen hinsichtlich der Gebrauchstauglichkeit, Messsicherheit und Sicherheit für elektromechanische Blutdruckmesssysteme fest, die zur nichtinvasiven Messung des arteriellen Blutdrucks am Oberarm, am Handgelenk und am Oberschenkel eine aufblasbare Manschette verwenden. Er legt auch Anforderungen für deren Zubehör und der Prüfverfahren fest.
Dieser Teil der EN 1060 gilt für elektromechanische Blutdruckmesssysteme, bei denen der Manschettendruck elektronisch gemessen wird, der Blutdruck jedoch entweder manuell mit Hilfe eines Stethoskops oder automatisch bestimmt werden kann.
Zusätzliche Anforderungen an die Sicherheit von automatischen, periodischen, indirekt messenden Blutdruck-Überwachungsgeräten legt EN 60601-2-30:2000 fest.
Dieser Teil der EN 1060 ist in Verbindung mit EN 1060-1 anzuwenden.
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguine
La présente partie de la norme EN 1060 spécifie les exigences en matière de performance, efficacité et sécurité
requises pour les systèmes électromécaniques de mesure de la pression sanguine qui, au moyen d'un brassard
gonflable, sont utilisés pour la mesure non invasive de la pression sanguine artérielle. Elle spécifie également les
exigences pour leurs accessoires et décrit les méthodes d'essai.
La présente partie de la norme EN 1060 s'applique aux systèmes électromécaniques de mesure de la pression
sanguine, dans lesquels la pression du brassard est mesurée électroniquement, mais qui permettent de déterminer
la pression sanguine soit manuellement à l'aide d'un stéthoscope, soit automatiquement.
L'EN 60601-2-30:1995 spécifie des exigences de sécurité complémentaires pour les appareils de surveillance de la
pression sanguine relevée indirectement, automatiquement et périodiquement.
La présente partie de l'EN 1060 doit être utilisée conjointement à la norme EN 1060-1.
Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za avtomatizirane sisteme za merjenje krvnega tlaka
Ta del EN 1060 določa zahteve za zmogljivost, učinkovitost in varnost elektromehanskih sistemov za merjenje krvnega tlaka, ki se s pomočjo napihljive manšete uporabljajo za neinvazivno merjenje arterijskega krvnega tlaka na nadlahti, zapestju in stegnu. Določa tudi zahteve za njihove dodatke in podaja preskusne metode. Ta del EN 1060 velja za elektromehanske sisteme za merjenje krvnega tlaka, pri katerih se tlak v manšeti meri elektronsko, vendar pa se krvi tlak lahko določa ročno s stetoskopom ali avtomatsko. Dodatne varnostne zahteve za opremo za avtomatski, ciklični posredni nadzor krvnega tlaka določa EN 60601-2-30:1995. Ta del EN 1060 se mora uporabljati v povezavi z EN 1060-1.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za avtomatizirane sisteme za merjenje krvnega tlakaNichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische BlutdruckmesssystemeTensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguineNon-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-3:1997+A2:2009SIST EN 1060-3:2000+A2:2010en,fr,de01-marec-2010SIST EN 1060-3:2000+A2:2010SLOVENSKI
STANDARD
SIST EN 1060-3:2000+A2:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1060-3:1997+A2
November 2009 ICS 11.040.55 Supersedes EN 1060-3:1997English Version
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguine
Nichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische Blutdruckmesssysteme This European Standard was approved by CEN on 27 January 1997 and includes Amendment 1 approved by CEN on 24 November 2005 and Amendment 2 approved by CEN on 17 October 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-3:1997+A2:2009: ESIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Cuff .55Display .66Units .67Requirements .68Test methods .99Information supplied by the manufacturer . 19Annex A (informative)
Bibliography . 22Annex ZA (informative)
####Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$$$$ . 23 SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 3 Foreword This document (EN 1060-3:1997+A2:2009) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This Eur
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